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Generics/Biosimilars Collection

  • ID: 2705643
  • Report
  • FirstWord Publishing
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Dossier Report Collections

The authors are pleased to showcase Report Collections, focused on areas of critical importance to Pharma's success, present and future. These Collections deliver expert views, exclusive analysis and insights to help you, your colleagues, and company gain a knowledge edge in each of the topics. Specially priced, these Report Collections provide significant value.

Report Collections include:

- Biosimilars
- Emerging Markets
- Market Access
- Medical Affairs
- Pharma Marketing

The 'Generics/Biosimilars Collection' comprises the following titles:

- Charting the Biosimilar and Biobetter Development Pipeline (2013)

- Biosimilar Defensive Plays -- assessing the options

- Branded Generics: Strategies and Tactics for Winning in Latin America

- Biosimilars in Emerging Markets (Volume 1 and Volume 2)

*PLEASE NOTE: This is a bundle package containing multiple titles
Note: Product cover images may vary from those shown
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***Charting the Biosimilar and Biobetter Development Pipeline (2013)***

If you need to understand the important biosimilar and biobetter drug developments worldwide then this report is critical.

The promise of biosimilars has been great but beyond the first wave of products progress has been slow. With a number of high-value biologics, particularly monoclonal antibodies such as Herceptin, Avastin, Remicade and Humira, losing patent expiry in the coming years the potential for biosimilars remains high. With greater clarity on regulatory approval and the demand of health payers for low cost medicines, the drive to develop a viable biosimilar market will continue to grow.

Who are the companies involved? What does their portfolio look like? What stage are they at? Which products offer the best potential in terms of competitor development? Critical questions needing robust answers. That is where Charting the Biosimilar and Biobetter Development Pipeline (2013) comes in.

Charting the Biosimilar and Biobetter Development Pipeline (2013) will help you to:

- Understand the landscape of biosimilar/biobetter development through pipeline analysis of all known biosimilar developers worldwide

- Drill down to discover the levels of potential biosimilar and biobetter competition by therapy area, drug class, development status, and country

- Establish the level of biosimilar/biobetter competition to leading brands

- Learn which biosimilar developers are potential future competitors or collaborators

- Interrogate the development portfolio of over 300 companies and discover which are the leaders in biosimilar/biobetter development

- Identify development hotspots and know where research is taking place


The massively expanded second edition of this leading drug intelligence report provides a complete, practical and highly-detailed insight into the status of 868 biosimilar/biobetter drugs in development from over 300 companies worldwide. Widely considered to be the most comprehensive analysis of its type, Charting the Biosimilar and Biobetter Development Pipeline (2013) is delivered in two modules:

Biosimilar Datafile – New this edition!

Enjoy the practical benefits of a Microsoft Excel file containing data on biosimilar and biobetter drugs currently marketed or known to be in clinical development worldwide. Each drug can be seen in the context of data on their biologic reference products and content can readily be filtered on key indicators such as:

- Product Name/Development Code
- Developer(s)
- HQ Location
- Reference Product
- Therapy Area
- EU Patent Expiry
- US Patent Expiry
- Originator Company
- Product Type
- Stage of Development (US)
- Stage of Development (EU)
- Brand Name (reference products)
- Sales Value (reference products)

Using the tables provided you can effortlessly drill down into the content to identify biosimilars/biobetters in development by country, company, ATC classification, stage of development, and therapeutic area. Better still, the data can easily be exported to your own analytics or competitive intelligence system.

Biosimilar Development Analysis Report

This completely updated and expanded report volume utilises the Datafile content to produce more than 200 clear tables, charts, graphs and maps to provide “at a glance” insights into high-level trends and significant developments. Areas covered include:

- Leading biosimilar companies - number of biosimilar products in portfolio
- Geographic distribution of biosimilar/biobetter research
- Biosimilar development pipelines by 14 compound class and therapy areas
- Biosimilar development pipelines by therapy area
- Biobetter developments by compound class and therapy area
- Biobetters in development by 13 therapy areas

Who Should Read This Report?

Product managers at pharma/biotech companies with original biologics:

Identify how many biosimilars versions of your products are being developed and by whom

Product managers at biosimilar developers:

Know how many biosimilars are being developed in different therapy areas or of different originator products so that you can identify opportunity gaps/areas with less competition

Heads of licensing at pharma/biotech companies: Use the database to identify biosimilars developers that may want to license in/out their products – whilst also assessing the competitive environment for any products that they may currently license.

Investment managers at venture capital firms, seed funding bodies and investment banks:

Assess the investment potential of companies and their development pipelines: the risks are high but potential reward is great for those that bring product to market.

***Biosimilar Defensive Plays -- assessing the options***

Although biological therapeutics have developed into an increasingly valuable segment of the pharmaceutical market, the commercial impact of biosimilar products has, to date, been fairly insignificant. However, that's set to change.

Five of the world's best-selling innovator drugs, with collective sales of $35 billion in 2012, will shortly lose patent protection, making them vulnerable to biosimilar competition. Developers of biosimilars will also benefit from the recent establishment of an abbreviated regulatory pathway for the approval of biosimilars in the United States.

With the biosimilar market on the brink of expansion, the need for robust guidance on defensive strategies has been recognised, focusing on two main areas: delaying approval of competing biosimilars; and sustaining product revenues in the face of the competitive challenge.

In creating this unique report, expert opinions were sought on factors that have influenced decisions to date and how these will impact further developments.

Key Benefits

Generic defence strategies are well documented, but many of these are either less relevant or inapplicable to biosimilars. With 'Biosimilar Defensive Plays - Assessing the Options', you will learn which generic defence strategies are effective against biosimilars, and which contexts call for specific biosimilar defence strategies. You'll also be informed about how different strategies may be appropriate according to interchangeability status, orphan drug status, and whether the product is a paediatric therapy.

This insightful report brings you completely up to date with the biosimilar competitive landscape, and gives you the information you need to strengthen your brand and sustain revenues against an emerging threat. Specific topics addressed include:

- State-by-state variations of biosimilar legislation in the U.S. market
- The pronounced difference in the uptake of the two main biosimilar products in Europe
- Non-patent approaches, e.g., exclusivity, lobbying, citizen petition, and interchangeability
- Which marketing and pricing strategies can be adapted from the branded drug market
- Technological leadership through the development of biobetters

'Biosimilar Defensive Plays - Assessing the Options' is designed to answer your strategic and tactical questions, such as:

- How can I sustain market exclusivity without a valid patent?
- Why are some biotechnology companies partnering with biosimilar companies?
- What does the new U.S. regulatory pathway for biosimilars mean for developers of these products?
- What tactics can we employ to delay market entry of biosimilars?
- How can we build brand loyalty for our branded biologic in a more crowded marketplace?

Expert Views Include:

- John Ansell, director, John Ansell Consultancy
- Sandy Eisen, chief medical officer, Frontline Pharma Consulting
- Steven Flatman, head, R&D Biosimilars, Lonza Biologics
- Paul Greenland, vice president, biologics, Hospira
- A portfolio development PM for autoimmune diseases within a German-based pharmaceutical company
- Diem Nguyen, general manager, biosimilars business unit, Pfizer
- Warwick Smith, director-general, British Generic Manufacturers Association

Report Highlights:

- Up-to-date summary of biosimilar product development and sales
- Insights into why biosimilars have had limited commercial impact to date, and how that will change
- A look at seven major companies in particular need of defensive strategies
- Tactics for delaying or preventing approval of biosimilars-with real-world examples
- Defensive sales, marketing, pricing, and drug development strategies

Key Quotes

“On the production side, process patents and the technology they cover could be core to the production of a particular biosimilar and they could well expire well after he actual product use patent, so that's been an interesting lesson learnt.”
-- Steven Flatman, head of R&D Biosimilars, Lonza Biologics

“Companies have used their market strength and relationships with key stakeholders to present a negative perception about biosimilars. They especially stressed data on the poor quality of copy biological products produced in Southeast Asia, and used this to imply that biosimilars approved in the EU would be of poor and variable quality.”
-- Paul Greenland, vice president, Biologics, Hospiram

“The very firm, thick, black lines between being an originator company and a generic company are getting much thinner and fainter, and we are just going to see people coming to the market with a range of products competing in a different way.”
-- Warwick Smith, director-general, British Generic Manufacturers Association

***Branded Generics: Strategies and Tactics for Winning in Latin America***

It's a $66 billion market—and getting bigger every year. The time is ripe for action. Yet for all the appeal and potential returns of investing in Latin America's burgeoning branded generics market, there are hurdles.

For pharma companies seeking entry into the diverse, complex and emerging Latin American market, challenges exist on all fronts. Consumers have an embedded preference for known brand names or cheap alternatives. The sector is increasingly becoming consolidated. Regulatory reforms continue to favour local manufacturers. And politics across borders are as diverse as official reimbursement policies.

Yet one thing remains constant: The moment to invest in the Latin American branded generics market has arrived.

Like a clear roadmap across complex terrain, Branded Generics: Strategies and Tactics for Winning in Latin America offers critical knowledge into how pharmaceutical companies can leverage their global experience into a region transitioning from sales to marketing models. Filled with on-point information and insights into everything from the importance of long-term commitment to building consumer loyalty amongst the rising middle class, the dossier lays bare the issues—and answers—to making profitable in-roads.
Key Benefits

The Latin American market promises much to those with a long-term commitment and a deep-seated understanding of regional needs. Understanding those needs is critical for success. While the hurdles are many—and constantly shift as governments change—an agile sales force and sophisticated messaging will gain the upper hand. Branded Generics: Strategies and Tactics for Winning in Latin America holds the key to ensuring that success. Amongst the benefits, this report will help you to:

- Understand how to gain access to the dynamic and evolving $66 billion Latin American pharmaceutical industry
- Build brand awareness through regional and national cultural tie-ins rather than direct-to-consumer advertising
- Encourage brand fidelity through loyalty programmes and ‘classic brand' portfolios
- Leverage added-value services to combat bioequivalent and cheap alternatives
- Manage the threat from government-protected industries and avoid saturated markets

Key Quotes

“Buying a generics maker makes sense for large companies; they can optimise their supply chain and have one or two plants that make a lot of different products…but in Mexico it's the small companies that have done well in generics.” Xavier Tello, Independent healthcare industry expert

“As a manufacturer, you should be committed to deliver your product and add value to society. But you also have the business question: in a high-risk market like Venezuela, you have to be there like you do in Brazil…but you also have to face reality.” Rodrigo Bonilla, Astellas Pharma

“Patients don't often differentiate between an original product and a branded generic…most people think they are buying original products.” Karina Mendez, Market Access Manager for Merck Sharpe & Dohme, Argentina

Key Report Features:

- Access to local industry experts with extensive operational experience in the Latin American branded generics markets
- Current intelligence about trends in regulation, pricing, IP and competition across various regions
- Up-to-date market data for billion-dollar branded pharma markets
- Case studies examining how successful companies build brand awareness through sports sponsorships and loyalty programmes
- Insights from innovator companies competing in hospital-driven niches, such as oncology

Branded Generics: Strategies and Tactics for Winning in Latin America answers key questions:

- Who are the key stakeholders, now and going forward?
- How are branded generics defined in each country?
- What works best for marketing off-patent drugs?
- Who represents the greatest challenge—local manufacturers, large retailers or other pharmaceutical companies?
- What are the key elements to investing in local manufacturing and partnerships?

***Biosimilars in Emerging Markets (Volume 1 and Volume 2)***

There are few areas of the pharmaceutical market more hotly debated than biosimilars yet the pathway to developing a viable global product marketplace is not clear. Biosimilar interest is being driven by the potential offered by a range of high-value brands which will be subject to patent challenges in the next 5-10 years such as Roche's Herceptin and Avastin.

The US market remains the big prize for biosimilars but is stalled with an untried regulatory process. Europe is more advanced but there are significant barriers to entry. It is no surprise, then, that biosimilar developers are turning to emerging markets as a preferred market entry point.

The fundamentals of biosimilars in emerging markets are sound: high unmet clinical need in large and expanding populations, growing GDP and health spending, increasing patient expectation and often amenable regulatory regimes all provide a fertile environment for biosimilar products. Many biosimilar companies in emerging markets are developing networks and alliances outside of the US and Europe which is providing valuable revenue and knowledge of international trade. Are we seeing a 2-speed biosimilars sector in which emerging markets and companies are taking a lead?

Understanding this complex market requires a detailed analysis of the trends which are shaping its development. Biosimilars in Emerging Markets is a 2-volume report which provides both a comprehensive overview of the biosimilars sector and highly-detailed expert analysis of the issues that are affecting developments on the ground in a range of emerging markets including Korea, India, China, Brazil, Russia and Turkey.

VOLUME 1: Putting emerging markets and companies into global context

This detailed volume succinctly reviews the biosimilars sector and will ensure you have a complete working brief of the current state of emerging markets in their international context. It provides a review of regulations covering biosimilars, identifies sales and patent expiry of leading biological brands and looks at market value and biosimilar pricing. There are country-by-country appraisals of leading emerging economies which examine the biosimilar operating environment along with company profiles of 23 local biosimilar developers with pipeline analysis for leading organisations.

VOLUME 2: Drilling down into emerging markets: local industry experts share their insights

What trends are driving biosimilars in emerging markets? Many countries have the need for biosimilars but do not have the development or manufacturing capacity to produce biosimilars for their own population. At the other end of the scale, a good deal of government interest and incentive for private companies has established the necessary framework for national/regional supply with long term ambitions for US/Europe. Even so, biosimilar companies may face challenges even with their own markets such as patient and clinical concerns over safety and quality. Volume 2 brings together highly-detailed market analysis with contributions from local industry experts whose clear insights provide a real world perspective of opportunities and challenges which must be overcome now and in the future.

Key quotes from Volume 2 of this report:

From Brazil...
“The government's goal is to build internal biotechnology and biomanufacturing capabilities, not provide foreign drug makers with unfettered access to the Brazilian pharmaceutical markets. The government's bottom line is to reduce Brazil's dependence on expensive, imported drugs.”
Kai Wolf
Genericpharma 2.0

From China...
“Most companies do not think beyond their local market. With 60 plus companies going after the same biosimilar portfolio, companies looking globally may have a strategic advantage and emerge as a winner,”
H Fai Poon
R&D Director
Hisun Pharma China

From India...
“In addition to our success in India, Biocon supplies 60% of the world's biosimilar insulin to emerging markets like Mexico, Brazil, the Middle East, North Africa and many parts of Southeast Asia”.
Kiran Mazumdar Shaw
CEO and Chairman of Biocon
Biosimilar Manufacturer

From Russia...
“We don't consider European or US markets as our priority in the long term. We are focused in the short term on markets of Russia with Southeast Asia and Latin America as mid-term goals.”
Roman Ivanov
VP of R&D Biocad
Biosimilar Manufacturer

On South Korea...
“The public and physician perception of biosimilars is critical for their acceptance in the Korean market. We believe that there needs to be huge investments in educational and marketing activities in both pre-and post-launch of these products.”
Paul Coleman
Hanwha Biologics

The benefits of this 2 volume report...

- Critically evaluate which emerging markets are best placed to exploit biosimilars
- Evaluate the patent expiry profile of leading brands likely to be subject to biosimilar competition
- Identify the position, products, pipelines and ambitions of leading companies from emerging markets
- Gain valuable expert insights as to what the real situation is in emerging markets and their approach to biosimilars
- Bring clarity to your understanding of the often confused regulatory pathways to be found worldwide
- Knowledgeably define strategic responses to the opportunities and threats from biosimilar development in the emerging market world

Do you know:

- Which emerging market companies have got biosimilar versions of Roche's Herceptin in development?
- With which companies has Korean biosimilar company Celltrion struck alliances?
- What role Korean electronics giants Samsung and LG are playing in the biosimilars area?
- How Roche has responded to falling sales of MabThera as it comes under pressure from Dr Reddy's Reditux biosimilar in India?
- What the data requirements are for biosimilar applications in Latin America and how they vary between countries?
- How the Brazilian government is incentivising biosimilar developers?
- How Turkey can play an influential role in the markets for biosimilars in the Middle East?
- Which Russian companies are building new bio-manufacturing plants?
Note: Product cover images may vary from those shown
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